ISO 9001 Training
Understanding ISO 9001:2008
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ISO 9001 TrainingUnderstanding ISO 9001:2008
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1 Scope 1.1 General This International Standard specifies requirements for a quality management system where an organization: a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. NOTE 1: In this International Standard, the term “product” only applies to a) product intended for, or required by, a customer, b) any intended output resulting from the product realization processes. NOTE 2: Statutory and regulatory requirements can be expressed as legal requirements. |
ISO 9001 Training Key Explanation
Points and Tips:
ÞYour QMS must do two things - 1. Meet
requirements consistently and 2. Enhance customer satisfaction in three different ways (see
above).
Ability refers to the capability of your organization to - determine your
customer needs and requirements; design and develop product; know-how and capacity to manufacture product; package
product; deliver on time; provide service and support; etc;
Consistency is being able to
repeat your capability within
specified parameters for quality as defined by customers, your own organization or regulatory bodies. Can you
consistently make conforming product or service, day in day out?
To achieve and
demonstrate your capabilities, you must effectively plan, operate and control the processes, within your
organization that provide them. These processes collectively form the scope of your quality management system (QMS).
The
effectiveness application of your QMS can be determined by - how well QMS activities and results measure up to planned
performance indicators.
Continual
improvement of the QMS is achieved by - increasing the ability of the
QMS to meet requirements through raising the performance indicators and more efficient use of resources.
Assurance of
conformity to requirements may be achieved by providing confidence
that requirements will be fulfilled. This confidence may be achieved through - implementing prevention based
controls; conducting internal/external audits; 3rd party certification of your QMS;
etc.
This standard
provides specific requirements to effectively plan, operate, control and improve your QMS processes. These
requirements focus on prevention based controls and to a lesser extent detection based controls, as well as
continual improvement of your QMS.
It is important
to note that the ISO 9001 standard does not specify requirements for
product. The focus of all ISO 9001 requirements is on your
QMS and its processes. By effectively
controlling and continually improving your QMS processes, there will obviously be a positive impact on product
quality performance.
Don’t
overlook regulatory requirements applicable to your organization. These requirements may come from your customer; the
industry you are in; from within your own organization; or state or federal organizations. You may need to apply
regulatory requirements to your suppliers and outsourced processes (subcontractors).
Your ultimate
objective is to enhance customer
satisfaction. You achieve this by planning, operating and improving
your QMS (PDCA) to effectively meet customer and regulatory (stakeholder)
requirements.